iSR'obot Mona Lisa

Basic Information

• Brand Name: iSR'obot Mona Lisa
• Primary DI: 08885014610382
• Version / Model: iSR'obot Mona Lisa 2.0
• Company Name: BIOBOT SURGICAL PTE. LTD.
• Labeler DUNS: 595137775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-29
• Public Version: 2
• Public Version Date: 2024-06-14
• Public Version Status: Update
• Public Device Record Key: c40a5a4a-99f7-4f25-ba42-dfbff33b3671

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2
OIJ	Biopsy Needle Guide Kit	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66831	Prostate stereotactic biopsy/ablation system	An assembly of electrically-powered devices intended to be used for trajectory planning and positioning of interventional instruments during computer-assisted transperineal prostate biopsy and ablation procedures under image-guidance, using real-time ultrasound imaging and pre-acquired MRI scans. It consists of a software-assisted console with a screen interface and a robotic electromechanical arm designed to guide the surgical instrument (e.g., prostate needle) to the target site following the pre-planned path set by the physician.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08885014610382	GS1